Abiraterone (Zytiga®) has been rejected for use in the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy. The manufacturer failed to make a submission but plan to submit a case in December 2013.

Lisdexamfetamine dimesylate (Elvanse®) has been accepted for as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate.

Mirabegron (Betmiga®) has been accepted for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. It is noted that alternative treatments are available at a lower drug acquisition cost.

A combination of rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride (Voractiv®) has been rejected for initial treatment of tuberculosis. The manufacturer failed to make a submission.

Vildagliptin (Galvus®) has been rejected for use in the treatment of diabetes as part of triple oral therapy with metformin and a sulphonylurea or in combination with insulin to achieve adequate glycaemic control. The manufacturer failed to make a submission.

Vildagliptin and metformin (Eucreas®) has been rejected for use in the treatment of diabetes as part of triple oral therapy with a sulphonylurea or in combination with insulin to achieve adequate glycaemic control. The manufacturer failed to make a submission.

Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.